Kornimate/medical-research-clean huggingface dataset:
qxzs in menopausal syndrome based on 16s rrna sequencing technology

Conditions: Menopause

Summary: the goal of this clinical trial is to explore the differences of intestinal flora and saliva flora between menopausal women, and the changes after medication, to find the association between the two and menopausal syndrome. the main questions it aims to answer are: * what are the differences in intestinal flora and saliva flora in menopausal women with hot flashes and sweating. * whether these differences change after using traditional chinese medicine and the association between intestinal, salivary flora and menopausal syndrome. 60 patients will be screened according to the clinical experimental criteria. they will be randomly divided into trial group (30 cases) and control group (30 cases). the test group takes traditional chinese medicine qingxin zishen decoction, and the control group takes oral femoston, comparing the two groups with analysis of symptom improvement, intestinal flora and salivary flora with 16s rrna sequencing technology.


Eligibility criteria:
inclusion criteria: * those who meet the diagnostic criteria for menopausal syndrome and the tcm heart and kidney syndrome differentiation criteria. * women between the ages of 45\~55. * the score of the modified kupperman menopausal symptom rating scale ≥ 15 points. * hot flashes and sweating≥ 3 times/day. * menopause ≥ 6 months. * fsh \> 10u/l during menopausal transition, 40u/l \> after menopause, and estradiol (e2) \< (10\~20) pg/ml. informed consent, voluntary test. the process of obtaining informed consent should be in accordance with gcp regulations. exclusion criteria: * other chinese and western drugs for the treatment of menopausal syndrome have been used after the onset of the disease. * have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival. * contraindications to hormone therapy: known or suspected pregnancy; in perimenopausal women, menstrual disorders should be ruled out to exclude pregnancy-related problems such as intrauterine pregnancy, ectopic pregnancy, and trophoblastic disease. unexplained vaginal bleeding: causes of vaginal bleeding include neoplastic, inflammatory, iatrogenic, traumatic, and ovarian dysfunction, which should be carefully identified before perimenopausal menstrual disorders are treated with sex hormones. known or suspected breast cancer. known or suspected sex hormone-dependent malignancy. active venous or arterial thromboembolic disease within the last 6 months. severe hepatic and renal insufficiency. * those who are unable to give full informed consent due to intellectual or behavioral disabilities. * suspected or confirmed history of alcohol and drug abuse. * allergies, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of this medicine. * patients who are participating in clinical trials of other drugs.

Keywords: menopause 16s rrna saliva flora intestinal flora
a study to determine whether urinary pge-m levels correlate with ulcerative colitis disease

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine whether urinary pge-m levels correlate with ulcerative colitis disease activity and to compare how well urinary pgem correlates with other noninvasive biomarkers of disease activity such as crp and fecal calprotectin.

the available clinical measures of ulcerative colitis activity can be overly influenced by functional symptoms. placebo response rates in clinical trials are high. several non-invasive biomarkers are currently available for assessing ibd disease activity including erythrocyte sedimentation rate, c-reactive protein and fecal calprotectin. although these markers hold some promise, their performance is less than ideal. what is needed is a simple, non-invasive biologic measure of uc disease. cyclooxygenase-2 (cox-2) is involved in prostaglandin e2 (pge2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. we have developed an assay to quantify the major urinary metabolite of pge2, pge-m. pge-m has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls. we recently showed that pgem was a sensitive and specific marker of crohn's disease activity (accepted for publication at ddw 2006).

Eligibility criteria:
inclusion criteria: * outpatient male or female 18 years or older * confirmed diagnosis of ulcerative colitis * informed consent obtained * able to give blood, urine and stool samples * will undergo a diagnostic colonoscopy of part of routine ulcerative colitis care exclusion criteria: * unable to give consent * crohn's disease * does not meet inclusion criteria * pregnant

Keywords: ulcerative colitis pge-m fecal calprotectin disease biomarkers
study of lanreotide autogel in non-functioning entero-pancreatic endocrine tumours

Conditions: Endocrine Tumors

Summary: the study will compare the difference between lanreotide autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.


Eligibility criteria:
inclusion criteria: * endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease * no hormone related symptoms * well or moderately differentiated tumour confirmed by histology * tumour lesions which are measurable by a ct or mri scan exclusion criteria: * previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days * treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide * had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for 5 years * pregnant or lactating * females must use adequate contraception during the study

Keywords: non functioning entero-pancreatic tumours
treatment of refractory/relapsed non-hodgkin lymphoma with cd19-tricart cell therapy

Conditions: Non-hodgkin Lymphoma,B Cell

Summary: this is a single arm, open-label, phase ⅰ study, to determine the safety and efficacy of cd19-tricar-t, an autologous tri-functional anti- cd19 chimeric antigen receptor (car)-positive t cell therapy, in refractory/ relapsed cd19 positive non-hodgkin lymphoma (nhl).

the tri-functional anti-cd19 chimeric antigen receptor contains an anti-cd19 scfv, a pd-l1 blocker, and a cytokine complex, enabling the cd19-tricar-t to simultaneously targeting the cd19 positive nhl cells，blocking the inhibitory pd-l1 signal and stimulating t/nk cell activation and expansion.

Eligibility criteria:
inclusion criteria: 1. all subjects must personally sign and date the consent form before initiating any study specific procedures or activities; 2. all subjects must be able to comply with all the scheduled procedures in the study; 3. histologically or cytologically confirmed cd19 positive non-hodgkin lymphoma; 4. at least one measurable lesion per revised iwg response criteria; 5. aged 18 to 69 years; 6. expected survival ≥12 weeks; 7. eastern cooperative oncology group (ecog) performance status of ≤2; 8. systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks; 9. all other treatment induced adverse events must have been resolved to ≤grade 1; 10. laboratory tests must fulfill the following criteria: anc ≥ 1000/ul, hgb \>70g/l, platelet count ≥ 50,000/ul, creatinine clearance ≤1.5 uln, serum alt/ast ≤2.5 uln, total bilirubin ≤1.5 uln (except in subjects with gilbert's syndrome); exclusion criteria: 1. presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring iv antimicrobials for management. simple uti and uncomplicated bacterial pharyngitis are permitted if responding to active treatment; 2. patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. the specific selection is ultimately determined by the investigator; 3. lactating women; 4. active infection with hepatitis b (hbsag positive) or hepatitis c virus (anti-hcv positive); 5. known history of infection with hiv; 6. subjects need systematic usage of corticosteroid; 7. subjects need systematic usage of immunosuppressive drug; 8. planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study; 9. other reasons the investigator think the patient may not be suitable for the study.

Keywords: car-t tricar-t cd19-tricar-t non-hodgkin lymphoma nhl cd19-car-t
a study of mk-8527 in participants with moderate and severe renal impairment (mk-8527-008)

Conditions: Renal Impairment

Summary: the goal of this study is to evaluate the effect of moderate and severe renal impairment (ri) on the pharmacokinetics (pk), safety, and tolerability of mk-8527. there will be no hypothesis testing in the study.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: moderate and severe ri * with the exception of ri, is in sufficient health for study participation. * has stable renal function. healthy * matches mean age to participants with moderate and severe ri. * has normal renal function. exclusion criteria: the main exclusion criteria include but are not limited to the following: all participants * history of cancer (malignancy). * positive test results for human-immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv). * had a major surgery or lost significant volume of blood within 56 days prior to dosing. * donated plasma within 7 days prior to dosing. moderate and severe ri * failed renal transplant or had a nephrectomy. * end stage renal disease requiring dialysis. * any significant arrhythmia or conduction abnormality. * has non-sustained or sustained ventricular tachycardia.
sample collection study for the cellmax life circulating tumor cell and circulating tumor dna platforms for the early detection of colorectal cancer and adenomas

Conditions: Colorectal Cancer Screening

Summary: the purpose of this study is to collect clinical specimens from subjects with a diagnosis of colorectal cancer/advanced adenoma or undergoing a screening colonoscopy and meeting study eligibility criteria.


Eligibility criteria:
inclusion criteria: to enroll in cohort a, a subject must: * be 45-80 years of age (inclusive) at the time of screening. * be recently diagnosed with primary colorectal cancer or advanced adenoma with plans to surgically remove the target lesion. to enroll in cohort b, a subject must: * be 45-80 years of age (inclusive) at the time of screening. * be planning to undergo a screening colonoscopy within 30 days after providing signed informed consent. exclusion criteria: to enroll in cohort a, a subject must not have: * inflammatory bowel disease (ibd) * personal or family history of colorectal cancer syndromes or other hereditary cancer syndromes to enroll in cohort b, a subject must not have: * personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer. * personal or family history of familial adenomatous polyposis (fap). * personal or family history of hereditary non-polyposis colorectal cancer syndrome (hnpcc or lynch syndrome). * positive fecal occult blood testing (fobt) within the previous 6 months. * positive fecal immunochemical testing (fit) in the previous 6 months. * colorectal resection for any reason other than sigmoid diverticular disease. * overt rectal bleeding within the previous 30 days. * personal history of any cancer diagnosed \<5 years prior. * inflammatory bowel disease (ibd), including chronic ulcerative colitis (cuc) and crohn's disease. * colonoscopy within the previous 9 years. * barium enema, computed tomographic colonography, or sigmoidoscopy within the previous 5 years. * ≥ 2 first-degree relatives who have been diagnosed with colorectal cancer (note: first degree relatives include parents, siblings and offspring). * 1 first-degree relative with crc diagnosed before the age of 60. * have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 30 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy. * have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
prevalence of eed and quality of life evaluated by gastroesophageal reflux disease (gerd)-q in korean gerd patients

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to asses the eed symptom prevalence in koran gerd patients with typical reflux symptom and to evaluate quality of life with the scales including gerd q.


Eligibility criteria:
inclusion criteria: * gerd patients who have experienced heartburn or acid regurgitation during past 7 days * gerd patients who have already undergone endoscopy before enrolment exclusion criteria: * involvement in the planning and conduct of the programme * the person who took the medicine such as ppi or h2ra during the last 7 days * severe systemic disease

Keywords: gerd korea typical symptom quality of life naturalistic epidemiological
study of the safety and efficacy of long-term rilonacept treatment for the prevention of gout flares

Conditions: Gout

Summary: the purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.


Eligibility criteria:
inclusion criteria: key inclusion criteria: * male or female participants aged 18 to 80 years; * previously met the preliminary criteria of the ara for the classification of the acute arthritis of primary gout; * serum uric acid greater than or equal to 7.5 mg/dl at the screening visit; * a self-reported history of at least 2 gout flares in the year prior to screening. exclusion criteria: key exclusion criteria: * pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug; * participants requiring dialysis; * participants who had had an organ transplant; * persistent chronic or active infections; * previous exposure to rilonacept; * use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the screening visit.
negative predictive value and nic of beta-lactam antibiotics.

Conditions: Allergy

Summary: the researchers are trying to evaluate how much medication is required for allergy skin testing and to determine the likelihood that patients with a negative test truly don't have an allergy to the tested drug of skin testing to commonly used antibiotics.

this study will be a prospective study to accurately determine the negative predictive value of skin testing with beta lactam containing antibiotics other than penicillin . it is hypothesized that the concentrations that should be used for beta lactams are actually much lower than previously recommended and that the higher incidence of identifiable beta lactam induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Eligibility criteria:
inclusion criteria: * all adults \> or = to 18 y/o undergoing surgery exclusion criteria: * minors under the age of 18 y/o, adults unable to consent, or those adults with previous allergic reaction history during previous surgeries.
antismoking effects of electronic cigarettes in subjects with schizophrenia and their potential influence on cognitive functioning.

Conditions: Tobacco Smoking in Schizophrenic Patients

Summary: it is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. to date there are no large randomised trials of e-cigarettes in schizophrenic smokers. a well-designed trial is needed to compare efficacy and safety of these products in this special population.

the investigators have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. the trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. the investigators will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. the main strengths of the scaris study are the following: it's the first large rct on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).

Eligibility criteria:
inclusion criteria: * schizophrenic subjects (according to dsm-iv-tr criteria) from throughout sicily, (italy), who smoke tobacco cigarettes, in stable phase of illness. * smoke ≥10 factory made cig/day, for at least the past five years * age 18-65 years * in good general health * not currently attempting to quit smoking or wishing to do so in the next 30 days (a specific test will be included to check their unwillingness to quit) 6 months * committed to follow the trial procedures. exclusion criteria: * use of smokeless tobacco or nicotine replacement therapy * pregnancy or breastfeeding. * current or recent (less than 1 yr) past history of alcohol and/or drug abuse * other significant co-morbidities according to the investigator's clinical assessment

Keywords: addiction, schizophrenia, electronic cigarettes
folate metabolism in normal weight and obese women of child-bearing age

Conditions: Obesity; Neural Tube Defects

Summary: the purpose of this study is to determine if there is a difference in the short term response in serum folate after a single dose of folic acid in normal weight and obese women of childbearing age.

current recommendations established in 1998, specify that all women capable of becoming pregnant consume 400 micrograms of folate daily from supplements, fortified foods, or both, in addition to consuming food folate from a varied diet. despite this recommendation, obese women have a lower folate status than women of normal weight which suggests that obesity may have a negative impact on folate metabolism. therefore, the objective of this study is to determine if there are differences in the metabolic response to a single dose of folate between normal weight and obese women of child bearing age. the two groups of women will be given the currently recommended amount of folic acid, 400 micrograms, and blood samples will be taken before the vitamin is given and at various points afterwards to determine serum folate response to the folate dose. results of this research should help determine if folate requirements are higher for obese than for non-obese women. the long-term goal of this and follow-up studies is to generate data that will contribute to the evidence base used by scientific advisory panels to determine whether dietary folate intake recommendations should be based on body weight.

Eligibility criteria:
inclusion criteria: * female 18-35 yr * caucasian * body mass index 18.5 - 24.9 or \> 30 kg/m2 exclusion criteria: * currently pregnant, pregnancy within the past 12 months * greater than 2 previous pregnancies * use of prescription drugs other than oral contraceptives * chronic disease (diabetes, hypertension, epilepsy, cancer, kidney disease, cardiovascular disease) * acute illness (e.g. pneumonia, urinary tract infection, mononucleosis) * use of antibiotics in past 30 days * current smoker * use of dietary supplements including multivitamins in the past 30 days * significant weight change in past 12 months * typical alcohol consumption of 2 or more drinks per day * consumption of any alcohol in the week preceding testing

Keywords: folic acid folate pharmacokinetics women of child bearing age
safety and efficacy of cryocor™ cryoablation for paf

Conditions: Atrial Fibrillation

Summary: a multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of paf

the purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the cryocor(tm) cardiac cryoablation system for treating symptomatic paroxysmal atrial fibrillation (paf) in comparison to treatment with anti-arrhythmic medications alone. this study also evaluates the safety profile of the cryocor(tm) cardiac cryoablation system when used in this same setting.

Eligibility criteria:
inclusion criteria: * at least 3 episodes of paf within 6 months * refractory to at least one drug * therapeutic anticoagulation * signed informed consent exclusion criteria: * persistent af * structural heart disease * prior ablation * contraindication present

Keywords: cryoablation atrial fibrillation
dry run of the screenurself trial

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia; Human Papilloma Virus; HPV-Related Cervical Carcinoma

Summary: the proposed study is the dry run preceding the screenurself trial.

the screenurself trial will be embedded in the flemish organized cervical cancer screening program. the goal of screenurself is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) human papillomavirus (hpv) testing, and if positive, reflex 1) cytology on a pap smear (standard of care) and 2) methylation marker triage (index test). the two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a pap smear (i.e., current practice within the organized cervical cancer screening program in flanders). the dry run which is the subject of this clinical trial will test the study materials and data flows developed for the interventional study arms (c, d, e and f) of the screenurself trial. the primary outcome of the dry run is to check if the flow for data- and sample collection is ready for start of the screenurself trial, and if optimizations are deemed necessary before start of the trial.

Eligibility criteria:
inclusion criteria: * eligible for cervical cancer screening within the organized population-based screening program in flanders: * female * residing in flanders, belgium * no history of total hysterectomy * no (former) diagnosis of cervical or uterine cancer * 30 - 64 years old (birth year 1959 - 1992) exclusion criteria: * being pregnant or 6 weeks postpartum (self-reported after receiving the study letter/package) * participation during menstruation or within the 3 following days is a contraindication * not able to understand the study materials and participation form (informed consent form)

Keywords: biomarker first-void urine vaginal sample screening triage self-sampling
xalacom and combination of unfixed latanoprost and timolol in subjects with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open Angle; Ocular Hypertension

Summary: to compare efficacy and safety of xalacom with the combination of unfixed latanoprost and timolol in subjects with open-angel glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * patients with open-angle glaucoma or ocular hypertension exclusion criteria: * closed/barely open anterior chamber angle or a history of acute angel closure glaucoma * ocular surgery within 3 months